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  AIDS 2002 Barcelona
Barcelona, Spain July 7-12 2002
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Kaletra Did Not Result in Methadone Withdrawal
  Mike Saag, leading researcher and doctor from the University of Alabama, is speaking right now on treatment interruptions and recommended that he does not recommend patients & doctors use treatment interruptions. If a patient wants to stop therapy they should only do so in a study. He expressed concern about CD4 decline & viral load increase after stopping therapy. The initial interest in treatment interruptions was because early research suggested that if a patient goes off therapy the resistant virus would be resensitized to the drugs. This has found not to be true. Although research into this question continues. Several reports & studies will be discussed about this topic tomorrow. C Katlama will be presenting data from her study called GigaHAART on patients who interrupt therapy before starting a salvage regimen to see if the interruption helps promote a better response.
This study on methadone was reported here in a poster by S Rappaport, L Maroldo-Connelly, and Abbott. Rappaport & Maroldo are with West Midtown Medical Group in New York City. West Midtown is a treatment facility that provides integrated addiction treatment, primary medical care, HIV care & I think methadone maintenance. They reported here on the effect of Kaletra on the blood levels of methadone for 18 patients on maintenance methadone. Although studies in HIV-infected and in healthy volunteers (HIV-negative individuals) show methadone blood levels can be reduced, the question remained on whether patients would experience actual withdrawal symptoms. A previously conducted small study of 8 patients showed a reduction in methadone levels of 36% (CID 2002; 34:1143-45) but patients did not experience symptoms of withdrawal.
This study evaluated 27 patients (9 were considered ineligible), leaving 18 for evaluation. Patients were on a stable methadone dose for at least 1 month prior to starting Kaletra. Patients were excluded if they received medications within 2 weeks of starting Kaletra that are known to alter methadone clearance and affect methadone dose requirements. The study investigators followed the patients for withdrawal symptoms during the first 4 weeks after starting Kaletra. Patients were treatment naive or experienced.
Clinical manifestations of withdrawal were characterized as:
--constitutional symptoms (chills and sweats)
--gastrointestinal (nausea, diarrhea, abdominal pain, anorexia)
--central nervous system: (tremors, anxiety, yawning, pupillary diameter)
--skeletal muscle (myalgias - body aches, arthralgia, leg cramps)
--rhinorrhea and increased lacrimation ?
The methadone maintenance dose was 95 mg/day (range: 40-130) for an average of 38 weeks before starting Kaletra. No methadone dose changes occurred during the 4 week evaluation period. The average HIV viral load reduction for the first 12 weeks of Kaletra (plus nukes) was -2.40 log (range: -3.8 to +1 log) with 57% achieving <400 copies/ml. Average CD4 increase was 80 during the 12 week evaluation. One patient experienced nausea and vomiting that led to discontinuation of Kaletra after 2 days; however, no adverse events were reported for the remaining patients.
Of the 18 patients eligible for study: 11 were men, age 44 years, 15 were ART experienced, viral load was 4.7 log (about 70,000), CD4 was 175.
The authors concluded, 24/25 patients tolerated Kaletra without any complaints or reported adverse events. Use of Kaletra & methadone at the same time did no result in withdrawal symptoms. They concluded that there is no need to increase methadone dose when starting Kaletra. However, as a precaution it is recommended to monitor for opiate withdrawal because there can be patient variability. In methadone programs at Montefiore Hospital in NYC they monitor methadone maintenance patients starting any HAART treatment. They check methadone & HIV drug blood levels with lab tests and closely monitor patients for withdrawal symptoms. They check blood levels to confirm any patient complaints. This study also shows that patients on methadone maintenance can have successful HAART therapy. Preliminary studies also show that patients on methadone maintenance can also succeed with hepatitis C treatment. Group support & additional supportive services are necessary.